Perforating analytical test device

ABSTRACT

An analytical test device and method of use are taught. The device has a perforating sharp tip to contact the sample. The tip has an aperture permitting the sample to flow into a recess of the device without the application of vacuum. In the recess is a test means that is contacted by the sample flowing through the aperture and give the test results.

This application is the national phase under 35 U.S.C. §371 of PCTInternational Application No. PCT/FI99/00134 which has an Internationalfiling date of Feb. 13, 1998 which designated the United States ofAmerica.

THE TECHNICAL FIELD OF THE INVENTION

The present invention is related to a perforating analytical test devicefor hygienic and risk-free handling of hazardous samples comprising atest stick, which is placed in or can be placed into the device, whichis capable of penetrating the sampling vessel or the stopper thereofwithout the need of opening the stopper of the sampling vessel.

THE BACKGROUND OF THE INVENTION

Some biological samples, especially those clinical samples which aretaken for detection or diagnoses of infectious diseases are dangerousand unpleasant to handle. Fecal samples are not only unpleasant, but inaddition to being inconvenient, the handling of the sample can bedangerous, particularly, if the sample contains pathogenic organisms,such as salmonella-, cholerae-, EHEC-bacteria, rotavirus or dysenterycausing Entamoeba histolytica. In addition to fecal samples, many othertypes of samples originating from hospitals or medical centersconstitute a health risks to those carrying out the test. Samplescontaining toxic or radioactive substances forms another group ofhazardous samples.

Usually, when the test is carried out, the sample vessel or bottle isopened by removing the stopper in a place specially reserved for tests,which might constitute a contamination risk. Test sticks, such as thosedescribed in e.g. patent applications EP 284 232, EP 291 194, WO94/15215 or some other of the multitude of test strip-,dipstick-variants developed during the past decades are then dipped intothe sample solution and transferred to a test tube or some other vesselto develop the test results. The test stick is allowed to stand in saidvessel until the result is detectable or can be made detectable, eithervisually or by some apparatus or device capable of reading or monitoringthe result. Even if the test is performed with appropriate skill and theutmost care, a contamination risk always exists. When the stoppers ofthe sampling vessels are removed tiny drops of the sample solution mighteasily be splashed around and might contaminate the hands or clothes ofthose carrying out the test as well as the environment in which the testis carried out. When the test stick is transferred from the samplingvessel to the other vessel for developing, drops of the sample solutionmight drip down on the table or those performing the tests have to usesome alternative means to avoid dripping. Consequently, a risk ofcontamination is always present and wastes, which have to be handled ashazardous waste products are produced. The equipments and means used aswell as the environments have to be disinfected and sterilized when thetest or tests have been completed.

Sampling rods or swabs or sampling devices which are brought intocontact with a developing solution or reacting agents have beendescribed for example in the following patent applications JP 08005627,WO 95/25948, WO 96/28715, GB 1587174. None of the described devicesdisclose a system wherein a hazardous sample is collected in a samplingvessel and the sampling vessel is transported to another laboratorysometimes even by air. In such cases the sampling vessel must be made ofa strong and durable material to resist any accidents during transport.In the laboratory, the sample has generally been handled as describedabove, but it is not desirable that the person performing the test isexposed to open contact with the hazardous sample. The device of thepresent invention solves the problem by providing a combined perforatingand analytical test device which is capable of perforating a strong anddurable, even air-transportable sampling vessel without exposing theperson performing the test to open contact with the sample.

SUMMARY OF THE INVENTION

Thus, the objective of the present invention is to provide a combinedperforating analytical test device, which decreases the disadvantagesconnected with the hazardous systems of prior art and diminishes therisk of contamination caused by the removal of stoppers from the vesselsand transfer of the test sticks from one vessel to another. At the sametime the need of repeated and extensive disinfection measures isdecreased and the perforating analytical test device can be destroyedusing appropriate measure without exposing the person performing thetest, at any time, to any contact with the sample. The purpose of thepresent invention is above all to protect those performing the test fromunnecessary contamination risks and possible inconveniences caused byodors by providing a device, which is easy to handle and enables thetest to be carried out without opening the sampling vessel andtransferring the test stick to another vessel.

Further scope of the applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

A BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only, and thus are not limitativeof the present invention, and wherein:

FIG. 1 depicts the perforating analytical test device viewed from oneside. The tip portion with the aperture and recess is situated on theoutside wall of the tip portion. The side of one of the handle walls ofthe grip portion is shown in full, whereas the opposite handle is notvisible in FIG. 1.

FIG. 2 depicts the perforating analytical test device viewed from theside on which the back wall connecting the two handle walls of the gripportion is shown.

FIG. 3 depicts a longitudinal section of the perforating analytical testdevice in which the back wall connecting the handle walls of the gripportion is shown in the center and the inner side of the opposite handlewall is indicated. The opening into which the test stick is placed orcan be placed as well as the recess is also shown.

FIG. 4 depicts a separate test stick, with four optional zones. The teststicks can either be placed into the device during the manufacturingprocedure or which can be sold separately and placed before use into theopening specifically provided in the perforating analytical test deviceby the person performing the test.

FIG. 5 depicts a perforating analytical test device without the teststick. The handle walls and the back wall with the niche is shown aswell as the tip portion with the aperture and recess.

FIG. 6 depicts a closed model of the perforating analytical test devicewith a test stick, which has been placed into the opening in tip portion(not shown) during the manufacturing procedure. The reading zone of thetest stick is seen in the niche in the back wall of the grip portion insaid closed model of the device.

FIG. 7 depicts the perforating analytical test device into which theperson performing the test has placed a separate test stick. Part of theaperture can be seen in the grip portion, which has partly penetratedthe stopper.

FIG. 8 depicts a cross-sectional view from the central part of theperforating analytical test device with an opening for the test stickpassing through the middle of the device.

FIG. 9 depicts a stopper seen from below with the perforating analyticaltest device with an alternative design. The device has penetrated thestopper through an area on the stopper, especially designed to assistthe perforation. The area can be provided with some auxiliary supportingstructures.

FIG. 10 depicts the perforating analytical test device with thealternative design. The device is shown, when it has penetrated thestopper through the specially designed area. The device is seen from theupper side of the stopper.

THE DETAILED DESCRIPTION OF THE INVENTION

Definitions

In the description which follows, most terms are used in the same waythey are generally used in diagnostics, immunochemistry andbiochemistry. However, some terms are used in a somewhat different ormore extensive way. In order to provide a clearer and more consistentunderstanding of the specification and claims including the scope to begiven such terms, the following definitions are given.

The term “sampling vessel” means a bottle, or test tube or some othermeans into which the sample is collected or into which the samples, inthe form of a biopsy item or as the contents from a swab is diluted bythe aid of suitable diluents such as water, buffers, etc., to form a“sample solution”. The “sampling vessel” is preferably provided with astopper which can tightly fastened.

The term “stopper” means any sampling vessel closing device, which actsas a lock, cap, etc., and which assures that no leakage of the samplesolution can occur, e.g. during transport. The stopper can be snapped orscrewed or fastened by any means to the vessel. The stopper can beprovided with a region made of a thinner, softer or more elasticmaterial, which is more easily penetrable and said region can further bedesigned with supports which protects the test stick placed into theperforating analytical device and steadies the hand of the personcarrying out the perforation. The most important features of thesampling vessel or the stopper thereof as well as the perforating deviceare that they are made of a material, which is so elastic and flexiblethat they together form a water-tight joint, which is so tight andclosely fitted or almost glued together that no sample solution can leakor penetrate from the sampling vessel. Thus, the elasticity orflexibility characterizing polyethylene or polypropylene such aspolypropylene (PE), high density polyethylene (HD-PE), low densitypolyethylene (LD-PE) or polypropylene (PP) are advantageous.

By the term “test stick” an elongated analytical device in dip-sticksolid-phase format is meant. The test stick can be a test strip placedon or in a solid support or it can be any kind of absorbing stuffincorporated e.g. into a kind of column, the shape of which can vary.The test strip or column comprises the tracers and markers and reagentsrequired for carrying out the analytical test.

The term “hygienic” and “risk-free” means that the system containing thehazardous sample is closed in such a way that the person performing thetest is not exposed to open contact with the hazardous material and thecontamination risk is diminished and the need of decontamination andsterilizing measures is decreased.

The term “handling” included the optional insertion of the test stick,the perforation, the optional pushing and pulling of the perforatinganalytical test device or alternatively, turning the vessel upside downand back to upright position in order to avoid a surplus or excess, i.e.a redundant, disturbing absorption of the sample solution.

The term “hazardous” means that the sample contains risk causingmaterials, such pathogenic disease-causing organisms as well as toxic,corrosive or radioactive substances, which may contaminate theenvironment and the person handling the material.

The term “tip portion” means the portion, which penetrates andcorresponds to the blade of a knife. The term “pointed” means that thetip of the perforating device has a sharp end, which facilitates thepenetration. Thus, the “pointed tip” of the tip portion acts like theedge of the knife.

The term “grip portion” means the handle or helve, which is gripped ortaken hold of with the hand when the perforation is carried out.

The term “opening” means a hollow room inside the perforating analyticaltest device for the test stick.

The term “shaped” means formed during the manufacturing e.g. by moldingof plastics, or plasticizing.

The term “incorporating” or “incorporated” means that an item has beeninserted or placed into the appropriate device.

The term “aperture” means a hole of optional form on the outside wall ofthe perforating analytical test device.

The term “recess” means an opening on the outside of the device andwhich passes into the device, i.e. a hole, which is not blocked by thetest stick. Thus, the “recess” allows free access of the sample solutioninto the perforating analytical device and improves the absorbation intothe test stick.

The term “absorption” means that the sample solution is taken up in thewetting region of the test stick and transferred or moved by e.g.capillary forces or diffusion into the reagent containing zones orregions of the test strip or test stick.

The term “handle walls” mean the side walls of the grip portion, whichcan have two separate walls connected by the back wall. Alternatively,they can be form a shaped handle in one piece, which fits the hand ofperson performing the test. However, it is important that the handlewalls, include a niche for the test stick and an easy monitoring orreading of the results is facilitated from the reading zone of the teststick in the niche of the grip portion.

The term “connected” or “connecting” means that a supporting bridge isformed between the handle walls in the grip portion. “Test sticksupporting back wall” means said connecting wall, which alternativelycan be molded in one piece with the handle walls fitting the hand of theanalyser and incorporating a visibly situated place for the reading zoneof the test stick.

The term “hold improving means” is used to mean nibbles or protuberancesin form of spots or stripes, which aid the grip of the personperforating the sampling vessel or the stopper. Alternatively, the “holdimproving means” can be a sand-paper-like, rough structure on thesurface of the handle walls in the form of a coating or in situ preparedduring molding of the plastic.

“Wetting zone” means the part or region of the test stick, which iscontacting the sample solution and contains absorbing material capableof absorbing the sample solution. Preferably said part does not containany of the reagents incorporated into the test stick.

“Reading zone” means the part or region of the test stick wherein thetest results are detectable or can be made detectable either visually orby suitable means. The result is generally readable as, yes or no,depending upon the lines developing or not developing on the readingzone.

“Protruding” means that e.g. the “grip portion” of the device issticking out in a visible position outside the sampling vessel and thestopper.

The term “package combination” means a kit comprising a set ofdisposable, ready for use, perforating analytical test devices and/orseparate test sticks with perforating devices.

The term “disposable” means that the device is used only once andthereafter destroyed by appropriate means.

The term “desired time” is the time, which is sufficient for theabsorbed sample solution to reach the reading zone of the test stick.

The General Description of the Invention

The objective of the invention is made feasible by a perforatinganalytical test device, having a pointed tip portion and a grip portion.The tip portion comprises a sharp pointed tip prepared by a material,preferably a plastic material, which is sufficiently durable and toughenough to allow the perforation of the sampling vessel or the stopperthereof and to prevent damages to the test stick while the perforationstep is carried out. In addition the perforating analytical test deviceacts as a protector for the test stick during storage and transport. Atthe same time the material or substance of which the perforating deviceis made of should be sufficiently elastic to allow the perforatingdevice together with the stopper to form a joint which is so tight thatno sample solution can penetrate through the linings of the joint. Theinside of the tip portion of the perforating device is provided with anopening, which is shaped so that the test stick used in the analyticaltest fits exactly into it. The opening runs through the tip portion, butthe outmost tip is solid and compact in order to be sufficiently strongand capable of penetrating the sampling vessels or stoppers. The contactbetween the test stick and the sample solution is made feasible throughthe apertures on the outer surface of the tip portion of the perforatinganalytical test device.

Optionally the contact is improved by a recess or a hole which allowsthe sample solution to flow into the device and wet the test stick. Theperforating analytical test device and the test stick should also becapable of forming such a tightly connected combination that no leakageof the sample solution can occur and the sample solution should only beabsorbed through the wetting zone into the test stick. No leakage ofsample solution should be allowed to occur, even if the vessel is turnedupside down.

The test stick can be placed into the perforating analytical test deviceduring the manufacture and sold as a disposable ready for use kit. Thetest kit can be placed into the perforating analytical test device insuch a way that the lower part of the test stick optionally reaches thesurface of the sample solution. Alternatively, the lower part of thetest stick does not reach the sample solution. In said case, in order toallow the absorption of the sample solution into the test stick, thesampling vessel has to be turned upside down. The grip portion of theperforating device protruding from above the stopper and the gripportion of the perforating device allows the test results to be seen sothat the results are easily readable.

The perforating device is pushed through the stopper of the samplingvessel. The stopper can be provided with a region made of a thinner,softer and/or more elastic material and further designed with asupporting structure, which not only supports and protects the teststick, but also assists the person performing the test to direct thepointed tip of the perforator appropriately and to avoid the pointed tipfrom sliding or slipping on the surface of the stopper. After theperforation, the test stick is allowed to come into contact with thesample solution in the bottom of the vessel.

Optionally the perforator is mobile, i.e. can be pushed and pulled tosome extent so that the test stick and the sample solution are not in acontinuous contact when the results are developed. Thus, excess orredundant sample solution is prevented from being absorbed into the teststick and possible disturbing the test results.

Consequently, the sample can be analysed without opening the stopper ofthe sampling vessel. The test stick can also be allowed to come incontact with the sample solution by turning the vessel upside down inwhich case the wetting zone of the test stick comes in contact with thesample for a short time through the aperture on the surface of the tipportion of the perforating device. The size of the tip of theperforating device is adjusted to the size of the test stick used in theperforating device as well as to the size of the sampling vessel. Thesize of the aperture on the surface of the tip must not be longer thanthe wetting zone of the test stick.

The surface of the sample solution in the sampling vessel shouldabsolutely not reach to the zone containing tracers, labelled particles,i.e. reagents. The sample solution should be absorbed through thewetting zone and such an amount of the sample solution should be allowedto be absorbed only in such an amount that it reaches the reading zone.Thereafter, the contact between the test stick and sample solution ispreferably broken. The sample solution is absorbed through the aperturethrough the wetting region and then it flows by capillary forces throughthe region containing the tracer, i.e. binding substances such asligands, antibodies and /or antigens, labelled particles, etc., until itreaches the reading zone. As the solution reaches the reading zone thesampling vessel is turned back to its normal upright position and theresult is allowed to develop. Accordingly, the wetting zone of the teststick is not more in contact with the sample solution. Thus, a redundantamount of sample solution is prevented from being absorbed into the teststick.

Thereafter, the test is allowed to develop without any possiblydisturbing movements until the result is visible. The result is recordeddirectly, e.g. visually from the test stick protruding above the stopperof the perforating analytical test device according to the invention.Finally, everything including the sample vessel, stopper, perforatingdevice and the test stick can be destroyed by appropriate means, byburning or alternatively sterilization or decontamination beforedisposing it. The test arrangements assure that the person performingthe test is not exposed to open contact with the hazardous samplesolution at any point of the analytical proceeding.

The device of the present invention and the use thereof for performinganalyses with a test stick is described in more detail by referring tothe attached FIGS. 1-10, wherein the reference numbers and/or lettersused refer to the corresponding features independent of the design ofthe perforating analytical test device.

In this connection it should be understood that the followingdescription and Figures are intended to be examples, which should in noway restrict the invention to the specific features shown in theFigures. On the contrary the scope of protection is intended to coverall modifications, equivalencies or alternatives, which contain thecharacteristics of the device as defined in the claims and include thepossibility of making a hygienic test with a test stick without openingthe stopper of the sampling vessel using a perforating analytical testdevice according to the present invention.

FIG. 1 depicts a side view from the outside of the perforatinganalytical test device. The perforating analytical test device comprisesa tip portion (1) and a grip portion (2). The tip portion (1) comprisesa sharp pointed tip, which is produced by a material, preferably of aplastic material, which is sufficiently hard and durable to perforate,pierce or penetrate the sampling vessel or the stopper thereof. Thesurface of the tip portion (1) is provided with an aperture (5), whichcontinues in a recess (6) into which the test stick cannot reach. Thegrip portion (2) comprises two opposite handle walls (7), one of whichcan be seen in FIG. 1. The handle walls (7) can optionally be providedwith hold improving means such as protruding spots, nipples and lines,which improve the grip and prevents the hand from slipping when thesampling vessel or stopper is perforated. The surface of the handle wallcan also be provided with a sandpaper-like or rough coating or thehandle walls can be provided with the structure during molding.

FIG. 2 shows another side view of the stopper perforating device. InFIG. 2 the sharp-pointed tip portion (1) and the handle portion (2) areshown. The aperture and recess are not shown from this point of view ofthe tip portion (1). In the grip portion (2) the back wall (8) providedwith a niche (9), and which supports the test stick and connects the twohandle walls (7) is shown. In the grip portion (2) the niche (9) isshaped or molded to fit the form of the test stick. Said niche (9),which is shaped or formed by the back wall (8) is made to facilitate theinsertion of the test stick, when it is pushed down into tip portion (1)through the opening (not shown in FIG. 2) in the tip portion (1). Besidethe niche (9), the back wall (8), forming a support to the test stick isshown.

FIG. 3 depicts a longitudinal section of the perforating analytical testdevice with the sharp-pointed tip clearly shown in the tip portion (1)and the handle walls of the grip portion (2). The tip portion (1)contains an optionally rectangular opening (3) for the test stick. Theopening (3) continues as a recess (6) into which the test stick cannotreach, but which facilitates free flow of the sample solution. In thegrip portion (2) the back wall (8) supporting the test stick can beseen. The niche is not indicated in FIG. 3. The test stick is insertedalong the supporting back wall (8) of the grip portion (2) and then intothe bottom of the opening (3) in the tip portion (1) leaving the recess(6) empty, which in turn facilitates free contact between the test stickand the sample solution to be absorbed into the wetting zone of the teststick.

FIG. 4 shows a separate test stick, which can be inserted into thestopper perforating device. The test stick comprises a wetting zone (a),a zone incorporating tracers preferably labelled with particulatevisible markers (b), a reading zone (c) and a zone (d), into which anyredundant or excess sample solution is absorbed.

FIG. 5 shows a perforating analytical test device, without any teststick. FIG. 5 shows the tip portion (1) with the aperture (5) continuinginto the recess (6), from which the sample solution is absorbed into thetest stick. The supporting back wall (8) with the niche (9) for the teststick connecting the two handle walls are shown.

FIG. 6 shows the perforating analytical test device with a ready fittedtest stick (4). The upper side of perforating device can optionally beclosed as indicated in FIG. 6, but the device can be open as well. InFIG. 6 the tip portion (1) and the grip portion (2) are shown. In thetip portion (1), the aperture (5), the length of which is not longerthan the wetting region of the test stick continues as a small recess(6) or hole, into which the test stick does not reach, but from whichthe sample solution is absorbed into the wetting zone of test stick (4).

FIG. 7 shows a perforating analytical test device, which has partlyperforated a stopper. The grip portion (2) contains a test stick (4)inserted by the person performing the test. The reading zone (c) and thegrip portion (2) protrudes out from the stopper of the perforatinganalytical test device. In the reading zone (c) the presence of linesindicate the results, generally interpretable as yes or no. The tipportion (1) of the perforating analytical test device has not beenpushed completely through the stopper (A) of the sampling vessel (B). Asa consequence the aperture (5) on the tip portion of the stopperperforating device can still be seen. The region (11) between theaperture (5) and the starting point of grip portion (2) indicates anarea which can be used to enable a certain mobility of the perforatinganalytical test device, if it is desired to push the device so that itcontacts the sample solution for a while and then pull it up to breakthe contact. When the test is carried out the aperture (5) on theoutside of the tip portion should be totally inside the sampling vessel(B) to avoid any contamination.

FIG. 8 shows a cross-section of the perforating analytical test devicejust in the center or middle of the device between the tip and gripportions viewed from above looking down into the tip portion. In FIG. 8the sides correspond to the handle walls (7). In the middle of FIG. 8the supporting shaped or molded back wall (8) forms the so called niche(9), which further supports the test stick.

FIG. 9 shows a perforating analytical test device with an alternativedesign and a stopper provided with an area with supporting structures(C). The device has penetrated the stopper (A) and is viewed from belowthe stopper. The tip portion (1) is optionally open and provided with anaperture (5) and recess (6) even if it is not so important in the openmodel. The grip portion (2) with the handle walls (7) are shown abovethe stopper. Hold improving means (10) in form of protruding stripes areshown on the left handle wall (7).

FIG. 10 shows the perforating analytical test device of FIG. 9 fromabove. The test stick (4) is inserted into the perforating analyticaltest device and the device has penetrated the stopper (A) through thearea, which is made of softer and more elastic material and has beenprovided with supporting structures (C).

The invention being thus described, it will be obvious that the same maybe varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the invention, and all suchmodifications as would be obvious to one skilled in the art are intendedto be included within the scope of the following claims.

What is claimed is:
 1. A perforating analytical test device for handlingsample solutions comprising: a sharp pointed tip portion insertable intoa sample solution and an opposite end for receiving a test means; thetip portion having an aperture in communication with a recess that isbetween the aperture and the opposite end wherein the recess is open tothe ambient environment through the aperature and the opposite endwhereby a portion of a sample solution can flow through the aperatureinto the recess without vacuum or applied pressure; and a grip portionconnected to the opposite end such that the recess is not occluded whenthe testing means is inserted in the opposite end and the test means canbe viewed.
 2. The device of claim 1, wherein the test means is a teststick when inserted into the device through the opposite end into therecess will simultaneously be in communication with the aperture andopposite end, the test stick being detachable from the test device. 3.The device of claim 1, wherein the test means is a test stick wheninserted into the device through the opposite end into the recess willsimultaneously be in communication with the aperture and opposite end,the test stick being mounted in and affixed to the test device.
 4. Thedevice of claim 1, wherein the tip portion is capable of penetrating asampling vessel or a stopper of a sampling vessel and wherein the recessis adjacent the aperture and opening and is sized such that the testmeans is not positionable therein.
 5. The device of claim 1, furthercomprising hold improving means for the grip portion, the hold improvingmeans including at least one of nibbles, protuberances and a roughenedsurface.
 6. The device of claim 1, further comprising a test means witha wetting zone and wherein the aperture in the tip portion is no longerthan the wetting zone of the test stick.
 7. The device of claim 1,wherein the test device is used with a sampling vessel and wherein thetest device includes a test means with a wetting zone, dimensions of thetest device are such that the wetting zone of the test means can becontacted with a sample in the sampling vessel for a predeterminedperiod of time.
 8. The device of claim 1, wherein the grip portionfurther includes two handle walls and a test means supporting back wall,the two handle walls being connected by the back wall.
 9. The device ofclaim 8, wherein the grip portion further includes a niche shaped tofacilitate support of the test means.
 10. The device of claim 1, furthercomprising a test means with a reading zone, the reading zone beingvisible when the test stick is inserted in the test device.
 11. Thedevice of claim 10, wherein the tip portion is capable of penetrating asampling vessel or a stopper of a sampling vessel and wherein thereading zone protrudes from and is visible outside the sampling vesselor the stopper and wherein the grip portion further includes a nicheshaped to facilitate support of the test stick.
 12. The device of claim1, wherein the device is produced for a material sufficiently strong anddurable for perforation of a sampling vessel or stopper and sufficientlyelastic and flexible for a water-tight joint between the test device andthe sampling vessel or the stopper.
 13. The device of claim 12, whereinthe device is made from plastics.
 14. The device of claim 1, wherein thetest device is a part of an analytical test kit which includesseparately packed perforating test devices and test means, the teststicks being insertable into the test device before use.
 15. The deviceof claim 14, wherein the test devices are disposable and wherein thetest means are preinserted in the test device before packaging such thatthe test devices are ready for use.
 16. A method for performing ananalytical test using a test device having a tip portion and a gripportion, the method comprising the steps of: providing the test devicewith a test means, the test means extending from the grip portion to thetip portion of the test device; penetrating the sampling vessel orstopper on a sampling vessel with the tip portion of the test devicewherein the test device comprises a sharp pointed tip portion insertableinto a sample solution and an opposite end for receiving the test means;the tip portion having an aperture in communication with a recess thatis between the aperture and the opposite end wherein the recess is opento the ambient environment through the aperture and the opposite endwhereby a portion of a sample solution can flow through the apertureinto the recess without vacuum or applied pressure; a grip portionconnected to the opposite end such that the recess is not occluded whenthe testing means is inserted in the opposite end and the test resultsfrom the testing means can be viewed; and contacting a sample solutionin the sampling vessel with the test means through an aperture in thetip portion; absorbing the sample solution through the aperture into thetest means for a time sufficient for the sample solution to reach thereading zone of the test means; and monitoring a result from the testdevice by viewing the reading zone of the test means.
 17. The method ofclaim 16, further comprising the step of destroying the sampling vesseland test device after the step of monitoring, the sampling vesselremaining closed through the step of destroying whereby a person usingthe test device is not exposed to the sample solution.
 18. The method ofclaim 16, wherein the test means is test stick having a wetting zone anda reading zone such that the reading zone is visible during the step ofmonitoring.
 19. The method of claim 18, further comprising the step ofturning the sampling vessel up-side down until the sample is absorbed inthe wetting zone of the test strip and reaches the reading zone andthereafter turning the sampling vessel into an up-right position until aresult is readable from the reading zone of the test strip.
 20. Themethod of claim 18, further comprising the step of avoid excessabsorption of the sample solution by pushing the test device intocontact with the sample solution and when the sample solution isabsorbed through the wetting zone and reaches the reading zone in thetest stick, the test device is pulled out of contact with the samplesolution to break contact therebetween, the aperture of the tip portionof the testing device remaining inside the sampling vessel or stopper ofthe sampling vessel after the test device is pulled out of contact.